Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um estudo de fase 2 de variação de dose de LY4100511 (dados 853) em participantes adultos com psoríase em placas moderada a grave

24 de julho de 2026 atualizado por: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Um estudo de fase 2, multicêntrico, randomizado, duplo-cego, controlado por placebo, grupo paralelo, de variação de dose de LY4100511 (DC-853) para o tratamento de participantes adultos com psoríase em placas moderada a grave

O objetivo principal deste estudo é avaliar a segurança e eficácia do LY4100511 em participantes adultos com psoríase em placas moderada a grave.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

222

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Dresden, Alemanha, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU
      • Hamburg, Alemanha, 22391
        • MensingDerma Research GmbH
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Alemanha, 72076
        • Universitatsklinikum Tubingen
    • Bavaria
      • Augsburg, Bavaria, Alemanha, 86150
        • Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
    • Hesse
      • Frankfurt am Main, Hesse, Alemanha, 60590
        • Universitätsklinikum Frankfurt
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Alemanha, 48149
        • Universitätsklinikum Münster
  • Canadá
    • British Columbia
      • Kelowna, British Columbia, Canadá, V1W 4V5
        • Interior Dermatology Centre - Probity - PPDS
      • Nanaimo, British Columbia, Canadá, V9T1W1
        • Skin Care West
    • Ontario
      • Barrie, Ontario, Canadá, L4M 7G1
        • Simcoderm Medical & Surgical Dermatology Centre
      • Hamilton, Ontario, Canadá, L8N 1Y2
        • Dermatrials Research Inc.
      • London, Ontario, Canadá, N6H 5L5
        • DermEffects - Probity - PPDS
      • London, Ontario, Canadá, N6A 5R9
        • Lovegrove Dermatology - Probity - PPDS
      • Markham, Ontario, Canadá, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canadá, L4Y 4C5
        • DermEdge Research
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35244
        • Cahaba Dermatology Skin Health Center
    • Arkansas
      • Bryant, Arkansas, Estados Unidos, 72022
        • Dermatology Trial Associates
    • California
      • Beverly Hills, California, Estados Unidos, 90212
        • Zenith Research, Inc.
      • Fountain Valley, California, Estados Unidos, 92708
        • First OC Dermatology Research Inc
      • Fremont, California, Estados Unidos, 94538-1614
        • Center for Dermatology Clinical Research
      • Los Angeles, California, Estados Unidos, 90045
        • Dermatology Research Associates
      • Santa Monica, California, Estados Unidos, 90404
        • Clinical Science Institute
    • Florida
      • Coral Gables, Florida, Estados Unidos, 33134
        • Driven Research
      • Hialeah, Florida, Estados Unidos, 33012
        • Direct Helpers Research Center
      • Ocala, Florida, Estados Unidos, 34470
        • Renstar Medical Research
      • St. Petersburg, Florida, Estados Unidos, 33713-8012
        • GCP Global Clinical Professionals, LLC
      • Tampa, Florida, Estados Unidos, 33613
        • ForCare Clinical Research
    • Illinois
      • Skokie, Illinois, Estados Unidos, 60077-1049
        • Endeavor Clinical Trials Center - Dermatology - Skokie
    • Maryland
      • Rockville, Maryland, Estados Unidos, 20850
        • Lawrence J Green, M.D, LLC
    • Texas
      • Webster, Texas, Estados Unidos, 77598
        • Center for Clinical Studies, LTD.LLP
  • Hungria
      • Gyöngyös, Hungria, 3200
        • Gyongyosi Bugat Pal Korhaz
      • Veszprém, Hungria, 8200
        • MedMare Bt
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungria, 4032
        • Debreceni Egyetem Klinikai Kozpont
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungria, 5000
        • Allergo-Derm Bakos Kft
  • Japão
      • Tokyo, Japão
        • Igarashi Dermatological Clinic
    • Aichi-ken
      • Nagoya, Aichi-ken, Japão, 450-0003
        • Nagoya City University Hospital
    • Hakkaido
      • Sapporo, Hakkaido, Japão, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japão, 890-0063
        • Katahira Dermatology Urology Clinic
    • Kumamoto
      • Kumamoto, Kumamoto, Japão, 861-4101
        • Ohyama Dermatology Clinic
    • Osaka
      • Sakai-shi, Osaka, Japão, 593-8324
        • Kume Clinic
    • Tokyo
      • Shinjuku-ku, Tokyo, Japão, 160-0023
        • Tokyo Medical University Hospital
      • Tachikawa, Tokyo, Japão, 190-0023
        • Tachikawa Dermatology Clinic
    • Toyama
      • Takaoka, Toyama, Japão, 933-0871
        • Shirasaki dermatology clinic
  • Polônia
      • Katowice, Polônia, 40-611
        • Centrum Medyczne Angelius Provita
      • Warsaw, Polônia, 02-665
        • Centrum Medyczne Reuma Park NZOZ
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polônia, 50-566
        • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
      • Wroclaw, Lower Silesian Voivodeship, Polônia, 50-381
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polônia, 00-710
        • Clinical Best Solutions
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Polônia, 35-055
        • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polônia, 80-382
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Pomeranian Voivodeship, Polônia, 81-537
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Polônia, 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polônia, 70-332
        • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polônia, 90-436
        • Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
  • Tcheca
      • Pardubice, Tcheca, 530 02
        • Pratia Pardubice a.s. - PRATIA - PPDS
      • Prague, Tcheca, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tcheca, 13000
        • Pratia Prague s.r.o. - PRATIA - PPDS
      • Prague, Tcheca, 160 00
        • Kozni ambulance Fialova, s.r.o. - CRC - PPDS
    • Praha 10
      • Prague, Praha 10, Tcheca, 10100
        • CLINTRIAL s.r.o.

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Critérios de inclusão:

  • Diagnóstico clínico de psoríase em placas durante 6 meses antes da randomização do dia 1 da linha de base
  • Deve ter índice de massa corporal (IMC) de 18 a 40 quilogramas/metro quadrado (kg/m2) (inclusive).
  • Deve estar disposto a descontinuar as terapias tópicas e/ou sistêmicas para psoríase antes da primeira dose da intervenção do estudo.
  • Deve concordar em evitar exposição prolongada ao sol e abster-se do uso de cabines de bronzeamento, lâmpadas solares e outras fontes de luz ultravioleta durante o estudo

Critérios de exclusão:

  • Teve um surto de psoríase clinicamente significativo durante as 12 semanas anteriores ao início do estudo, conforme avaliado pelo investigador.
  • Ter histórico de psoríase eritrodérmica, psoríase pustulosa generalizada ou localizada, psoríase predominantemente gutata ou psoríase induzida por medicamentos ou exacerbada por medicamentos.
  • Ter qualquer diagnóstico conhecido ou suspeito de condições inflamatórias que não sejam psoríase e artrite psoriática, incluindo, entre outros, artrite reumatóide, sarcoidose, DII (doença de Crohn ou colite ulcerativa) ou lúpus eritematoso sistêmico.
  • Ter um diagnóstico de artrite psoriática que requer, ou está atualmente recebendo, tratamento médico imunossupressor sistêmico (incluindo corticosteróides, imunossupressores e produtos biológicos).
  • Ter uma infecção aguda ativa atual ou recente. O participante não deve apresentar sintomas ou sinais de infecção confirmada ou suspeita e deve ter concluído qualquer tratamento anti-infeccioso apropriado por pelo menos 30 dias antes da triagem e até a randomização/linha de base.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: LY4100511 200 mg BID
Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.
Medicamento: LY4100511
Administrado por via oral
Experimental: LY4100511 400 mg BID
Participants received LY4100511 400 mg administered orally BID for 12 weeks.
Medicamento: LY4100511
Administrado por via oral
Experimental: LY4100511 800 mg QD
Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.
Medicamento: LY4100511
Administrado por via oral
Comparador de Placebo: Placebo BID
Participants received placebo administered orally BID for 12 weeks.
Medicamento: Placebo
Administrado por via oral

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
Prazo: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)
Prazo: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
Prazo: Week 12

Percentage of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement from baseline at Week 12. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe):

  • 0 = Clear: No signs of psoriasis; post-inflammatory hyperpigmentation may occur
  • 1 = Almost clear: Normal to pink lesions; no thickening; no or minimal focal scaling
  • 2 = Mild: Pink to light red color; slight thickening; mainly fine scaling
  • 3 = Moderate: Dull bright red erythema; moderate thickening; moderate scaling
  • 4 = Severe: Bright to deep red; severe thickening with hard edges; coarse scaling covering most or all lesions
Week 12
Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12
Prazo: Week 12
Percentage of participants achieving ≥50% reduction from baseline in PASI-50 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Prazo: Week 12
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
Prazo: Week 12
Percentage of participants achieving ≥90% reduction from baseline in PASI-90 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12
Prazo: Week 12
Percentage of participants achieving ≥100% reduction from baseline in PASI-100 at Week 12 without use of background antipsoriasis therapy were responders. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Week 12
Change From Baseline in PASI Score at Week 12
Prazo: Baseline, Week 12

Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.

The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Baseline, Week 12
Percent Change From Baseline in PASI Score at Week 12
Prazo: Baseline, Week 12

Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects.

The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
Baseline, Week 12
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12
Prazo: Baseline, Week 12

Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.

BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Baseline, Week 12
Percent Change From Baseline in the Percentage of BSA Affected at Week 12
Prazo: Baseline, Week 12

Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value.

BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement.
Baseline, Week 12
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
Prazo: Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.
Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511
Prazo: Predose at Day 8, 15, 29, 57 and 85
Ctrough,ss of LY4100511
Predose at Day 8, 15, 29, 57 and 85
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511
Prazo: Baseline up to Week 12

The number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of LY4100511.

A TEAE is defined as an AE that occurs during or after the first study drug administration and up to and including the follow-up visit.

A serious adverse event (SAE) is any untoward medical occurrence at any dose that:

  • Results in death
  • Is life-threatening (risk of death at the time of the event)
  • Requires inpatient hospitalization or prolongation of existing hospitalization (excluding elective admission for a stable pre-existing condition)
  • Results in persistent disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other medically important event that may jeopardize the participant or require intervention to prevent the above outcomes
Baseline up to Week 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Investigadores

  • Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de outubro de 2024

Conclusão Primária (Real)

24 de julho de 2025

Conclusão do estudo (Real)

4 de setembro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

16 de setembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de setembro de 2024

Primeira postagem (Real)

19 de setembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 18845
  • J5C-MC-FOAB (Outro identificador: DCE853201)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Dados anonimizados de nível de paciente individual serão fornecidos em um ambiente de acesso seguro mediante aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.

Prazo de Compartilhamento de IPD

Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na União Europeia (UE), o que ocorrer depois. Os dados ficarão disponíveis por tempo indeterminado para solicitação.

Critérios de acesso de compartilhamento IPD

a proposta de pesquisa deve ser aprovada por um painel de revisão independente e os pesquisadores devem assinar um acordo de compartilhamento de dados.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever